Clinical Characteristics of The First IMLYGIC™ Patients With Unresectable Stage IIIB-IVM1a Melanoma Treated in Routine Clinical Practice, in Selected European Countries (20140413)

Study identification

• EU PAS number:
  EUPAS17410
• Study ID:
  32544
• Official title and acronym:
  Clinical Characteristics of The First IMLYGIC™ Patients With Unresectable Stage IIIB-IVM1a Melanoma Treated in Routine Clinical Practice, in Selected European Countries (20140413)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany

  Netherlands

  United Kingdom
• Study description:
  The treatment landscape for melanoma (including targeted and immunotherapies) continues to evolve rapidly. There is a lack of availabledata outside of the clinical trial setting in relation to the patient, disease and treatment characteristics of patients who are prescribed IMLYGICTM as melanoma therapy, and the respective physician’s prescribing behaviour and rationale. Real-world data is thus warranted to inform on usual care practice with regards to IMLYGICTM use for the treatment of adults with unresectable metastatic melanoma. The purpose of this study is to collect data on the first EU patients receiving IMLYGICTM in a real world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 9 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:28/03/2016

Actual:28/03/2016

Study start date

Planned:31/07/2017

Actual:29/06/2017

Data analysis start date

Planned:01/05/2019

Actual:14/04/2019

Date of final study report

Planned:18/11/2019

Actual:25/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable